RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: OR extubation for Cardiac Surgery

We are studying whether waking patients up and removing the breathing tube (also known as "extubation") in the operating room after cardiac surgery improves postoperative recovery without causing harm.

Official registry: https://clinicaltrials.gov/study/NCT07757880 · Massachusetts General Hospital · enrollment listed as 120

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are OR extubation, or ICU extubation. The registry lists allocation as randomized. We are studying whether waking patients up and removing the breathing tube (also known as "extubation") in the operating room after cardiac surgery improves postoperative recovery without causing harm.

They plan to enroll about 120 people at 2 sites. Taking part typically means a procedure as part of the study plus check-ins.

Official title (unrewritten)

Randomized Evaluation of Operating Room Extubation Versus Intensive Care Unit Extubation After Cardiac Surgery

Interventions: OR extubation, ICU extubation

Primary outcome (registry wording): Hierarchical composite endpoint, ordered by clinical priority

Who it is for (from inclusion criteria)

Ages 18 Years to any
Adults (age 18+) scheduled for elective cardiac surgery requiring cardiopulmonary bypass
Low perioperative risk defined as STS Predicted Risk of Mortality (PROM) ≤ 3% based on the latest STS Adult Cardiac Surgery Database (ACSD) Risk Calculator
Deemed appropriate for OR extubation preoperatively by the attending cardiac surgeon

Who the registry excludes

Underlying pulmonary disease requiring use of home supplemental oxygen
Pre-capillary pulmonary hypertension (mPAP ≥ 25 mmHg or PVR \> 2 Wood units) on most recent right heart catheterization for any patient for which there is suspicion for pulmonary hypertension at the time of preoperative evaluation
Preoperative right ventricular dysfunction greater than mild on most recent echocardiogram
Obstructive sleep apnea with home CPAP or biPAP use or recommended use
Neuromuscular disease associated with respiratory muscle weakness including myasthenia gravis, Lambert-Eaton myasthenic syndrome, or muscular dystrophy
We will also exclude patients undergoing the following procedures:
Pulmonary thromboendarterectomy

Public study contact (from the registry)

Lauren Gibson, MD

617-726-3030

legibson@mgh.harvard.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

Massachusetts General Hospital — Boston, Massachusetts (recruiting)
Brigham and Women's Hospital — Boston, Massachusetts (not_yet_recruiting)

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FAQ about this NCT record

Is NCT07757880 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07757880?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07757880?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary